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Momenta Pharmaceuticals, Inc. (MNTA)
UBS Global Healthcare Conference Call
May 21, 2013, 11:00 a.m. ET
Rick Shea – Chief Financial Officer
Ami Fadia – UBS
Ami Fadia – UBS
Previous Statements by MNTA
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Okay, thank you very much, Ami. Before I begin the presentation, I would like to draw your attention to our Safe Harbor statement, and the risk factors included in our SEC filings. Momenta was founded based on analytical and characterization technologies that we apply to complex products. So these can either be complex drug products or pharmaceutical products that were originally approved under NDAs that they can also apply to biologics and so we are working on portfolio of products.
So we have two programs that are generic versions of NDA products. Generic Lovenox which is approved in July of 2010 and then we are working on a generic version of Copaxone, which is under review with the FDA. We have a biosimilars program that we are working in collaboration with Baxter and we have two novel programs one is a Novel Oncology Candidate and the second program involves the sialylation of antibodies particularly IVIG.
So let me move initially to Generic Lovenox and the current status of Generic Lovenox is that it's a fully competitive market. We have partnered that program with Sandoz Generic's Division of Novartis and Sandoz reported net sales in the first quarter of this year of $47 million. This is after having reported net sales of the product of $85 million in the fourth quarter 2012, so their sales are fluctuating from quarter-to-quarter.
We probably see prospectively the run rate for Sandoz sales of Enoxaparin, somewhat in the $50 million to $60 million range, but that certainly can fluctuate and continue to be impacted either by market share pressures or by pricing pressures. We are currently earning a 10% to 12% royalty on Sandoz sales of Enoxaparin.
We do want to emphasize that again, we were the first company to have Generic Lovenox approved, was approved in July of 2010 and during that period of time, when we were the only Generic Lovenox on the market, which was second half of 2010 and through 2011. We generated more than $400 million in profit share revenue during that period of time. So it's provided us a substantial amount of non-dilutive financing, but at the same time. It demonstrated the validity of our technology and our ability to work with the FDA to get a generic version of a very complex product approved, and we believe that the experience with Generic Lovenox also has applicability for our Generic Copaxone as well as the biosimilars.
As with many generic products, there has been litigation involved in the Generic Lovenox market suffice to say that, we initially obtained an injunction keeping our competitor of Amphastar and Watson off the market initially, that was overturned in the Court of Appeals, so we are now appealing that to the Supreme Court and we are hoping to hear in the next several months, whether the Supreme Court will take that, but even if the Supreme Court doesn't take it, we think that there are venues that we can argue the validity of those processed patents that we have on Enoxaparin and we will continue to work to enforce our IP.
Moving on to Generic Copaxone. We filed our ANDA on Generic Copaxone in December of 2007. It was accepted for review by the FDA in July of 2008. Now Copaxone is an ANDA product. It's not a biologic, it's not cell based manufacturing process. It's a synthetic polypeptide and we are working, have worked to prepare an application to the FDA, that we believe meets the ANDA standards for an interchangeable AB-rated Generic Copaxone, and this is what we are working towards and we continue to believe that we have supplied the FDA with enough information for them to approve our ANDA for Generic Copaxone. Again it's an AB-rated generic product.
This product too is subject to litigation, and District Court upheld the validity of Teva's nine Copaxone patents, but we appeal to that decision hearing was held on May 7th and certainly we believe that we made strong arguments as to why those patents should be invalidated. The bulk of those patents run to May of 2014, there is one processed patent that runs to September 2015, following that hearing on May 7th, there has been speculation that at September 2015, process patents is vulnerable and that the Judges of the Appeals Court may find that patent to be vulnerable, in which case, there is a possibility that we could be legally free to launch the product in May of 2014.
So this is something that we're certainly very aware of and we are working very closely with the FDA, in order to move that review forward and to get our ANDA approved in that timeframe on the assumption, that could be a timeframe in which we might have clearance to launch. So that's certainly a very high priority for us and an objective for us and we will be working hard to accomplish that.